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by Rebecca Stauffer, PDA | Jul 09, 2018

Check Out the Latest in New Technology Advancements in the PDA Journal

The July/August issue of the PDA Journal of Pharmaceutical Science and Technology features two articles spotlighting new technologies and applications. One looks at ozone generation during high-voltage leak detection and the other explores human factors for Ranibizumab 0.5 mg prefilled syringes.

Research

  • Yuh-Fun Maa, et al., “Vapor Phase Hydrogen Peroxide Decontamination or Sanitization of an Isolator for Aseptic Filling of Monoclonal Antibody Drug Product—Hydrogen Peroxide Uptake and Impact on Protein Quality“
  • Alejandra Nieto, Holger Roehl, “Sealing Behaviour of Container Closure Systems under Frozen Storage Conditions: Nonlinear Finite Element Simulation of Serum Rubber Stoppers“
  • Alberto Chillon, et al., “Introducing the Alba® Primary Packaging Platform. Part 1: Particle Release Evaluation”
  • Alavattam Sreedhara, et al., “Determination of the Acceptable Ambient Light Exposure during Drug Product Manufacturing for Long-Term Stability of Monoclonal Antibodies“

Technology/Application

  • Martin Becker, et al., “Ozone Generation during High-Voltage Leak Detection: Fiction or Reality?“
  • Andrew Antoszyk, et al., “Usability of the Ranibizumab 0.5 mg Prefilled Syringe: Human Factors Studies To Evaluate Critical Task Completion by Healthcare Professionals“

Case Study

  • Yushi Uetera, et al., “The Role of Heat-Tolerant Endotoxin-Retentive Ultrafilters (UFs) for the Remediation of Reverse Osmosis (RO) Plants Employed for Surgical Hand Antisepsis Using Periodic Thermal Disinfection—A Ten Year Longitudinal Experience Study in the Operating Theater“

Commentary

  • Kyle Zingaro, David Shaw, et al., “Implementation of Plate Imaging for Demonstration of Monoclonality in Biologics Manufacturing Development“

Erratum

  • John Mattila, et al., “ERRATUM: Retrospective Evaluation of Low-pH Viral Inactivation and Viral Filtration Data from a Multiple Company Collaboration“